Effect of Whole-Body Vibration on Plasma Sclerostin Level (WBV-SCL)

February 23, 2016 updated by: Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital

Effect of Whole-Body Vibration on Plasma Sclerostin Level in Healthy Young Adult Women

The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.

Fifteen healthy young adult women are planned to include in this study. All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period. Training duration will be short at the beginning but progressed slowly.

The amplitude of vibration will be 2 mm and the frequency of the vibration will be 40 Hz. The subjects will be asked to report negative side effects or adverse reactions in their training diary.

Previbration and postvibration (just after, 10.minute and 30.minute) levels of plasma sclerostin will be measured on first, second and fifth day of experiment. Sclerostin levels will be measured by human sclerostin ELISA kit.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Whole-body vibration has a strong osteogenic effect. The cyclic mechanical loading to the bone stimulates the osteocytes.

Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.

The aim of this study is to investigate effect of whole-body vibration on plasma sclerostin level in healthy young adult women.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Bagcilar Training & Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy women,
  • Women with ages varying between 20 and 40 years
  • Right-handed women

Exclusion Criteria:

  • Lower extremity problems

    1. Orthopedic problems: shortness of legs, congenital anomalies, etc.
    2. Joint disease (arthritis, joint prosthesis, etc.)
    3. Other painful pathologies in the lower extremities (fractures, tendinitis,bursitis, etc.)
    4. Circulation problems in the lower extremities
  • Dorsolumbar diseases: Vertebral fract, disc hernias, spondylodiskitis, etc.

  • Systemic disease cases

    1. Systemic bone disease: osteoporosis, osteomalacia, Paget's disease
    2. Hypertension (>135 mmHg systolic, >85 mmHg diastolic)
    3. Heart dis.(coronary dis, conduction/rhythm prob, cardiac pacemaker)
    4. Infectious diseases
    5. Endocrine diseases (Diabetes mellitus etc)
  • Neurological diseases (CNS problems, peripheral neuropathy)
  • Menstrual cycle disorders, amenorrhea, lactation, oral contraceptive use
  • Cases during the ovulatory period (11-16th day of menses)
  • Obesity (BMI >30 kg/m2) or low BMI (BMI <20 kg/m2)
  • Vertigo
  • Cognitive function disorders
  • Women whose blood samples were not taken in the time planned
  • Women whose blood samples hemolyzed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training
The whole-body vibration (WBV) training
Device: whole-body vibration (WBV)
All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.
Other Names:
  • Cyclic mechanical loading

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Sclerostin Level
Time Frame: 1 month
Change of plasma sclerostin level with whole-body vibration
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bagcilar Training and Research Hospital

Investigators

  • Study Chair: ILHAN KARACAN, MD, Bagcilar Training & Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

March 7, 2011

First Submitted That Met QC Criteria

March 7, 2011

First Posted (Estimate)

March 8, 2011

Study Record Updates

Last Update Posted (Estimate)

February 25, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEAH FTR-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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